Datascope Corp. recalls CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.

Recall date

June 17, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1943-2019

FDA classification

Class I

Brand / firm

Datascope Corp.

Sold / distributed

Worldwide distribution. US Nationwide, AFGHANISTAN , HUNGARY , PANAMA , ALGERIA , ICELAND , PARAGUAY , ARGENTINA , INDIA , PERU , AUSTRALIA , INDONESIA , PHILIPPINES , AUSTRIA , IRAN , POLAND , AZERBAIJAN , IRAQ , PORTUGAL , BAHRAIN , IRELAND , QATAR , BANGLADESH , ISRAEL , ROMANIA , BELARUS , ITAL…

Why it was recalled

If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.